BOGOTA, Colombia – After 12 years in relative stealth mode, Steba Biotech, a Luxembourg-based company owned by Israeli shareholders is launching operations in Latin America and submitted a marketing authorization application (MAA) to the EMA for Tookad, seeking approval to market the drug for the treatment of localized prostate cancer.
Steba completed a European phase III trial of Tookad for localized prostate cancer and other solid tumors. It was the first prospective randomized controlled trial evaluating the efficacy and safety of a focal therapy in prostate cancer. Data will be presented at the upcoming European Association of Urology scientific meeting in March.
After successfully conducting clinical trials in Mexico, the company filed and got the approval from Cofepris, the country´s health care surveillance agency, to commercialize Tookad (padeliporfin di-potassium) soluble focal vascular occluding agent, which interacts with a specially designed laser device also registered at Cofepris, to treat prostate cancer.
"We have different approaches in Latin America," Fabrice Harari, CEO and president of Steba Biotech, told BioWorld Today. "We have submitted our trial in Latin America, in three countries [Mexico, Panama and Peru]."
"As soon as those countries gave us the approval to start the trial, we started to recruit patients and before the other countries went through the process to start the trials, we finished the study," said Harari.
The company recruited 80 patients and found it easy to finish the trials.
"The study was very fast in Latin America, because in the region, the only proposed treatment for prostate cancer is radical prostatectomy. And in Latin American countries, not all of them at the same level, improved tremendously in filling the gap that they have in the health care domain. They are very open to welcome new treatment options for their populations," said Harari.
Steba Biotech established LLL Mexico, a subsidiary that has the rights to import and distribute their therapy, both the device and the drug, in the Latin American country.
"Mexico is a very large country with a large population. They still have a very low rate of incidence of prostate cancer, but the market is very important and the need is very important for the patients in Mexico, so the first country where we started the regulatory process in Latin America was Mexico," said Harari.
And taking Mexico as a reference in Latin America, the Luxembourg company is now filling in Latin America´s other giant: Brazil.
"Now we are in the process of filing the dossier to Anvisa in Brazil, and now that we have the first approval in Mexico, we are starting the process to go to other countries in Latin America, where at first, have some mutual recognition, or where Mexico´s approval can help in getting the approval in those countries," Harari explained.
Peru, Panama, Colombia and Argentina are some of the countries the company is considering as its first target.
"We have actually some demands from pharma companies that we eventually will be entering into discussion to distribute the products in a country basis, or maybe through a more regional agreement with a company that would be able to distribute the product in Latin America," Harari explained.
And the company is not just looking at Latin America. India is on the horizon.
"We did not yet approach Japan or China, or all Asian countries, we are looking for a strong partner in the region to take over the market. We can have some licensing agreement to license the market in Asia," said Harari.
Meanwhile, earlier this week, the company announced that it completed a phase III trial in Europe and will now file at EMA for market authorization.
"We already ordered a submission at the EMA, and we are now pursuing our program for filing at the U.S. FDA," said Harari.
The aim of the company is to treat patients, while preserving their quality of life, preventing side effects, such as those derived from radical surgery treatments, like erectile dysfunction and urinary incontinence.
"Because this is really the dark side of the radical surgery treatment," said Harari. "The main purpose of our innovative approach with the drug and procedure, is to allow patients to receive a treatment preventing them to have an alteration of their quality of life."
According to the Pan American Health Organization, it is estimated that up to 2.1 million people will die in 2030 due to the cancer in the Americas. In 2012, 47 percent of the cancer victims in the Americas, were located in Latin America and the Caribbean.